Randomized Comparison of a Cross Boss First vs
Randomized Comparison of a Cross. Boss First vs. Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusions: the “Cross. Boss First” trial Emmanouil S. Brilakis, MD, Ph. D on behalf of the Cross. Boss First Trial Investigators
Disclosure Statement of Financial Interest Consulting/speaker honoraria: Abbott Vascular, Amgen, Asahi, CSI, Elsevier, GE Healthcare, Medicure Employment (spouse): Medtronic Grants: Boston Scientific, Osprey VA CSP#571
Investigators Judit Karacsonyi, MD; Khaldoon Alaswad, MD; Peter Tajti, MD; Gerald C. Koenig, MD, Ph. D; Bavana V. Rangan, BDS, MPH; Kintur A. Sanghvi, MD; Sean C. Halligan, MD; Daniel Ice, MD; Raymond H. Allen, MD; Richard C. Kovach, MD; William J. Nicholson, MD; Vincent Varghese, DO; James E. Harvey, MD, MSc; Bilal Murad, MD; Anthony J. Spaedy, MD; Kenneth W. Baran, MD; Farouc A. Jaffer, MD, Ph. D; Erica Resendes, MS; J. Aaron Grantham, MD; Jose R. Martinez-Parachini, MD; Adam Salisbury, MD; Aris Karatasakis, MD; Anthony J. Hart, MD; Barbara A. Danek, MD; David M. Safley, MD; Rahel Iwnetu, MD; William L. Lombardi, MD; Ravi Hira, MD; Michele Roesle, RN, BSN; Creighton Don, MD; Subhash Banerjee, MD; James M. Mc. Cabe, MD; Emmanouil S. Brilakis, MD, Ph. D M. Nicholas Burke, MD; Houman Khalili, MD;
Background • Hybrid algorithm ADR as the initial crossing strategy ≥ 20 mm in length; clearly defined proximal cap; large size distal vessel • Asia-Pacific algorithm parallel wiring and intravascular ultrasoundguided crossing Brilakis et al. JACC Cardiovascular Interventions 2012; 5: 367 -79. ; http: //apcto. club/apcto-algorithm/
Study design • DESIGN: Investigator-Initiated, multicenter, randomized-controlled, clinical trial. • OBJECTIVE: To compare the upfront use of the Cross. Boss catheter vs. antegrade wire escalation for antegrade crossing of coronary chronic total occlusions. • SAMPLE SIZE: 246 • SITES: 11 US centers • FUNDING: Boston Scientific Corporation • PRINCIPAL INVESTIGATOR Emmanouil S. Brilakis, MD, Ph. D
Study design
Sample size calculation tt = 66. 0 ± 55 minutes tc = 46. 2 ± 55 minutes (30% relative reduction) = 0. 05 (2 -sided) Power = 0. 80 n per group = 123 total N = 246
Study flowchart
Participating centers University of Washington Medical Center, WA, W. Lombardi United Heart and Vascular Clinic, MN B Murad North Central Heart/Avera Heart Hospital, SD SC Halligan Minneapolis Heart Institute, MN, N Burke Henry Ford, MI, K Alaswad Mid America Heart Institute, MO, JA Grantham Missouri Heart Center, MO AJ Speady UT Southwestern and Dallas VAMC, TX, ES. Brilakis Massachusetts General Hospital, MA, F. Jaffer Deborah Heart and Lung Center, NJ KA Sanghvi Wellspan Heart and Vascular, PA WJ Nicholson
Enrollment by centers Site PI Randomized North Central Heart/ Avera Heart Hospital Dr. Halligan 32 Wellspan Heart and Vascular Dr. Nicholson 29 Missouri Heart Center Dr. Spaedy 28 Massachusetts General Hospital Dr. Jaffer 25 St. Luke's Mid America Heart Institute Dr. Grantham 24 University of Washington Medical Center Dr. Lombardi 21 Minneapolis Heart Institute Dr. Burke 19 Henry Ford Hospital Dr. Alaswad 16 Deborah Heart and Lung Center Dr. Sanghvi 9 United Heart and Vascular Clinic Dallas VA Medical Center (Coordinating Center) Dr. Murad 7 Dr. Brilakis 36 Total Randomized 246
Baseline clinical characteristics I Variable Cross. Boss Guidewire P value (n=122) (n=124) 65± 11 66± 10 0. 269 85 79 0. 244 31± 7 0. 792 Diabetes Mellitus, % 37 36 1. 000 Hypertension, % 87 89 0. 701 Age (years) Men, % BMI (kg/m 2)a
Baseline clinical characteristics II Cross. Boss Guidewire (n=122) (n=124) 52± 10 52± 14 0. 885 30 20 0. 101 44 42 0. 796 Prior CABG, % 28 23 0. 466 Prior CVD, % 7 10 0. 649 Prior PAD, % 12 14 0. 850 1. 0 (0. 9, 1. 2) 1. 0 (0. 9, 1, 2) 0. 511 Variable LVEF (%)a Congestive Heart Failure, % Prior Myocardial Infarction, % Baseline creatinine (mg/d. L)b a: mean ± standard deviation, b: median (interquartile ranges) P value
Angiographic characteristics I Cross. Boss Guidewire Variable (n=122) (n=124) ▪ RCA 65 64 ▪ LAD 18 20 ▪ LCX 17 15 P value CTO Target Vessel, % 0. 735 ▪ Other (LM) Calcification (moderate/severe), % 0 0. 8 42 46 0. 523 Proximal vessel tortuosity (moderate/severe), % 26 23 0. 553
Angiographic characteristics II Cross. Boss Guidewire (n=122) (n=124) P value Proximal cap ambiguity, % 16 15 1. 000 In-stent restenosis, % 23 23 1. 000 2. 6 (2. 3, 3. 1) 23 (12, 35) 2. 6 (2. 2, 2. 9) 20 (11, 37) Variable Proximal vessel diameter (mm)b Occlusion length (mm)b 0. 384 0. 799 J-CTO scorea 2. 02± 1. 10 2. 12± 1. 22 0. 511 Progress CTO scorea 0. 91± 0. 94 0. 95± 0. 96 0. 731 a: mean ± standard deviation, b: median (interquartile ranges)
Crossing strategies Variable Technical Success, % First Crossing Strategy, % ▪ Antegrade wire escalation ▪ Antegrade dissection and reentry ▪ Retrograde Successful Crossing Strategy, % ▪ Antegrade wire escalation ▪ Antegrade dissection and reentry ▪ Retrograde ▪ None Cross. Boss (n=122) Guidewire (n=124) P value 88. 5 87. 1 0. 846 22 98 <. 0001 77 1 1 1 24 51 50 18 8 22 17 10 <. 0001
Primary endpoints Crossing time Procedural MACE 10% p= 0. 323 p= 1. 000 8% 6% 4% 4. 03% 3. 28% 2% 0% Crossboss Variable Crossing time (min)b Guidewire Cross. Boss (n=122) Guidewire (n=124) P value 56 (33, 93) 66 (36, 105) 0. 323 Standardized mean difference: 0. 094 b: median (interquartile ranges)
Primary endpoints: ISR cases Crossing time Procedural MACE 10% p= 0. 046 p= 0. 302 8% 6% 4. 17% 4% 2% 0. 00% 0% Crossboss Variable Crossing time (min)b Guidewire Cross. Boss Guidewire (n=25) (n=24) 41 (23, 58) 66 (32, 111) Standardized mean difference: 0. 534 P value 0. 046
Procedural characteristics and outcomes Variable Procedural Success, % Total procedural time (min) b Total fluoroscopy time (min) b Total AK radiation dose Contrast volumeb Fluoroscopy time (min)b at crossing AK radiation dose at crossing Cross. Boss Guidewire (n=122) (n=124) 85. 3 109 (78, 185) 40 (28, 66) 83. 1 109 (75, 161) 37 (24, 65) 2. 18 (1. 23, 3. 56) 260 (168, 350) 2. 34 (1. 23, 3. 91) 250 (155, 329) 20 (11, 44) 25 (12, 48) 0. 638 0. 88 (0. 48, 1. 97) 1. 08 (0. 33, 2. 44) 0. 644 b: median (interquartile ranges) P value 0. 634 0. 670 0. 339 0. 752 0. 492
Secondary endpoints Total air kerma radiation dose Total procedure time p=0. 752 p=0. 670 Fluoroscopy time at crossing or total fluoroscopy time Contrast volume p=0. 638 p=0. 492
Procedural MACE Variable, % Procedural MACE Death Acute Q wave MI Acute MI Re-PCI Stroke Emergency CABG Pericardiocentesis Perforation Cross. Boss Guidewire P value (n=122) (n=124) 3. 28 4. 03 1. 000 1. 64 0. 81 0. 620 0. 496 0. 82 0 2. 46 0. 81 0. 368 0. 00 0. 81 1. 000 0 0 0. 00 3. 23 0. 060 1. 64 7. 26 0. 122
Equipment utilization Number of stents used p=0. 761 Number of microcatheters used p=0. 122 Number of balloons used p= 0. 274 Number of guidewires used p= 0. 465
Equipment costs
Limitations • Operators experienced in CTO PCI • In 22% of patients randomized to the Cross. Boss group crossing was achieved by advancing a guidewire through the Cross. Boss catheter • Initially selected strategy was not used in 3 cases of the Cross. Boss group and 2 cases of the guidewire group (repeat angiographic assessment with dual injection) • Subject to both type I and type II error – not powered for primary safety endpoint
Conclusions • As compared with a primary wire escalation strategy, upfront use of the Cross. Boss catheter for crossing CTOs was associated with: ¡ similar crossing time ¡ similar success and procedural MACE rates ¡ similar equipment costs • Further studies are needed to determine whether some subgroups (such as in-stent occlusions) are better suited for crossing using the Cross. Boss catheter.
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